MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number	1550225-38
Health Effect - Clinical Codes	Angina (1710); Thrombosis (2100)
Date of Event	06/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents.The reported patient effects of angina and thrombosis are listed in the xience sierra, everolimus eluting coronary stent system (eecss), electronic instructions for use(ifu) as known patient effects of coronary stenting procedures.The investigation determined the reported difficult to position and subsequent treatment appear to be related to the operational context of the procedure.A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
Event or Problem Description
It was reported that the patient was admitted with st elevation myocardial infarction.Coronary catheterization was performed and 5000 units of heparin and 180 mg of brilinta were administered.The 2.25 x 38 mm xience sierra stent was implanted in the 2nd obtuse marginal artery.No issues were noted during stent implantation.The patient remained in the cath lab following the procedure.About 20 minutes post procedure, the patient began to experience chest pain.Angiography was performed and it was noted that there was thrombus in the stented area.The vessel was rewired and balloon dilatation was performed.Additional stenting was attempted, but the stent delivery system could not pass through the implanted stent.No additional intervention was performed, as the vessel was opened after the balloon angioplasty.There was no adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 7599423
• Report Number: 2024168-2018-04465
• Device Sequence Number: 1422363
• Product Code: NIQ
• UDI-Device Identifier: 08717648227066
• UDI-Public: 08717648227066
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2019
• Device Catalogue Number: 1550225-38
• Device Lot Number: 8042341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Weight: 104